(197 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
This document describes the acceptance criteria and performance of "Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile" as part of a 510(k) summary for FDA approval.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard / Acceptance Criteria | Device Performance (Current Device) |
|---|---|---|
| Dimensions | ASTM D6319-10 (Standard specifies requirements for dimensions) | Meets |
| Length min 230mm | ||
| Width min 95±10 | ||
| Physical Properties | ASTM D6319-10 (Standard specifies requirements for physical properties) | Meets |
| Before Aging | ||
| Tensile Strength min 14 MPa | ||
| Ultimate Elongation Min 500% | ||
| After Aging | ||
| Tensile Strength min 14 MPa | ||
| Ultimate Elongation Min 400% | ||
| Thickness | ASTM D6319-10 (Standard specifies requirements for thickness) | Meets |
| Finger min 0.05mm | ||
| Palm min 0.05mm | ||
| Powder Free | ASTM D6124-06 (Standard specifies method for measuring powder) | Meets |
| ≤ 2 mg/glove | ||
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Under the conditions of the study, not an irritant. |
| Dermal Sensitization - ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c) (4) | Under the conditions of the study, not a sensitizer. | |
| Watertight (1000ml) | ASTM D5151-06 (Standard for detecting leaks, specifically AQL 2.5) | Passes |
| AQL 2.5 | ||
| Material | ASTM D6319-10 (Standard for Nitrile examination gloves) | Nitrile |
| Color | N/A (Comparison to predicate) | Blue |
| Texture | N/A (Comparison to predicate) | Finger textured |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use |
| Intended Use | The device is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for watertightness, tensile strength, etc.). However, it refers to compliance with ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10:2010(E). These standards typically specify the appropriate sampling plans and sample sizes required for testing.
The data provenance is Malaysia, as the submitter, WRP Rubber Products Sdn Bhd, is located in Sepang, Selangor Darul Ehsan, Malaysia. The data would be considered prospective in the sense that WRP Rubber Products Sdn Bhd conducted these tests for the purpose of their 510(k) submission, likely on batches of the device intended for market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. The provided document is for a medical device (examination gloves) that relies on engineering and biological performance standards, not diagnostic interpretative tasks. The "ground truth" is established by adherence to defined technical specifications and results from laboratory testing, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review processes, such as in clinical trials or image interpretation studies where discrepancies between initial assessments need to be resolved. For performance testing against objective standards, the results are typically quantitative and directly compared to the specified criteria without a need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This document concerns the regulatory approval of patient examination gloves, which are physical medical devices, not AI-powered diagnostic or assistive tools. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this document is for a physical medical device (examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by objective, standardized laboratory test results compared against predefined technical specifications and regulatory standards. For example:
- Dimensions: Measured values compared against minimum length and target width.
- Physical Properties (Tensile Strength, Elongation): Measured values compared against minimum performance criteria before and after aging.
- Powder Free: Measured amount of powder compared against a maximum limit (≤ 2 mg/glove).
- Watertight: Result of water leak test compared against the AQL 2.5 standard.
- Biocompatibility: In-vivo (likely animal) or in-vitro tests demonstrating lack of irritation or sensitization as per ISO 10993.
These are verifiable, quantitative, and qualitative outcomes from standardized test methods.
8. The Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning models. This product is a physical medical device and does not involve AI or machine learning, thus no training set is relevant.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.